Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Cerebral Palsy; Dental Plaque
• Interventions: Device: manual brushing; Device: off electric toothbrush; Device: electric toothbrush linked

• Registration Number: NCT02114801
• Lead Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri

Brief Summary

The aim of the present study was to determine the effectiveness of brushing with an electric toothbrush switched on and switched off in comparison to manual brushing for the removal of dental plaque in children aged four to 16 years with cerebral palsy.

Detailed Description

Advances in the design and type of movement of electric toothbrushes can determine the increase in effectiveness in the control of biofilm by caregivers and patients.There is a paucity of studies evaluating the effectiveness of the electric toothbrush compared to manual toothbrush specifically in patients with cerebral palsy.Only one study used the electric toothbrush in patients with cerebral palsy and demonstrated superiority of the electric toothbrush over the manual. However, the study investigated the effect of various cleaning strategies on symptoms of gingival inflammation, not specifically focusing on the comparison of the efficiency of removal of biofilm from the manual toothbrush and electric toothbrush. The primary objective of this study was to evaluate the effectiveness of the electric brush on and off the removal of dental plaque in subjects with cerebral palsy compared to manual toothbrush. The secondary objective was to characterize the study as socioeconomic population.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Study First Submitted: 2014-03-20
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-11
• Last Update Submitted: 2014-04-11
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• medical diagnosis of cerebral palsy

Exclusion Criteria

• who did not complete the cycle three brushings

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
manual brushing	manual brushing	manual brushing; Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro;
off electric toothbrush	off electric toothbrush	off electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
electric toothbrush linked	electric toothbrush linked	electric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro

Primary Outcome Measures

Name	Time	Method
Removal of dental plaque	after brushing three minutes duration	Before and after brushings were assessed levels of plaque accumulation. For evaluation of the dental plaque index of Quigley-Hein plaque modified Turesky was used.; The escovções were performed by caregivers.

Trial Locations

Locations (1)

Universidade Federal dos Vales do Jequitinhonha e Mucuri; 🇧🇷 Diamantina, Minas Gerais, Brazil